Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Talar Dome Total Ankle Prosthesis Recalled by Integra LifeSciences Corp. Due to The Salto Talaris and Integra XT Revision implant...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected Products
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
Quantity: 2029
Why Was This Recalled?
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
Where Was This Sold?
This product was distributed to 26 states: AL, CA, CT, FL, GA, HI, ID, IA, KS, KY, MD, MI, MO, MT, NE, NJ, NM, NY, NC, OH, OK, PA, TX, VA, WA, WI
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report